A Study of ARRY-520 in Patients With Advanced Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

A Phase 1/2 Study of ARRY-520 in Patients With Advanced Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637052
• Other study ID #: ARRAY-520-211
• Secondary ID: C4371005
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 18, 2008
• Est. completion date: June 21, 2010

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 2-phase study during which patients with select myeloid leukemias or advanced myelodysplastic syndrome (MDS), who have failed, refused or are not eligible for standard treatment, will receive investigational study drug ARRY-520. The study has 3 parts. The first phase of the study, Phase 1, has 2 parts. In the first part of Phase 1, patients with select myeloid leukemias or advanced MDS will receive increasing doses of study drug on different schedules in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 30 patients (per schedule) from the US will be enrolled in Part 1 (Completed). In the second part of Phase 1, patients with advanced MDS will receive the best dose of study drug and schedule determined from the first part of the study. Approximately 10 patients from the US will be enrolled in Part 2 (Completed). In the third part of the study, Phase 2, patients with acute myeloid leukemia (AML) or advanced MDS will receive the best dose of study drug and schedule determined from the first part of the study and will be followed to see what side effects the study drug causes and to see what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US will be enrolled in Part 3 (Withdrawn).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 21, 2010
• Est. primary completion date: June 21, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Key Inclusion Criteria (Part 2):

• Patients with either Intermediate-2 or High risk MDS or with AML (>20% bone marrow blasts) with stable low or normal white blood cell count (WBC). Patients should have failed one prior chemotherapy regimen which should have included a hypomethylating agent.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
• Discontinuation of prior treatment at least 2 weeks prior to the start of the study.
• Adequate hepatic and renal function.
• Additional criteria exist.

Key Exclusion Criteria (Part 2):

• Concurrent cytotoxic therapy, or biological, endocrine and immunological response modifiers.
• Previous radiation to >25% of bone marrow.
• Other active malignancies.
• Known positive serology for the human immunodeficiency virus (HIV).
• Central nervous system involvement as documented by spinal fluid cytology.
• Active, uncontrolled infection.
• Additional criteria exist

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Advanced MDS
• Leukemia
• Leukemia, Myeloid

Intervention

Drug:
• ARRY-520, KSP(Eg5) inhibitor; intravenous
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.

Locations

Country	Name	City	State
United States	Emory University School of Medicine, Winship Cancer Center	Atlanta	Georgia
United States	University of Texas, M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the maximum tolerated dose (MTD) of the study drug.		Part 1
Primary	Characterize the pharmacokinetics (PK) of the study drug.		Part 1
Primary	Characterize the safety profile of the study drug in terms of adverse events, dose limiting toxicity, clinical laboratory tests, weight, electrocardiograms and physical examinations.		Part 1 and Part 2
Primary	Assess the efficacy of the study drug in terms of incidence of complete remission (CR) and hematologic improvement (CRp).		Part 3
Secondary	Assess the efficacy of the study drug in terms of incidence of CR and CRp.		Part 1 and Part 2
Secondary	Characterize the safety profile of the study drug in terms of adverse events, dose limiting toxicity, clinical laboratory tests, weight, electrocardiograms and physical examinations.		Part 3